Probiotics and Infections in Children Attending Day Care... | NCT01014676

Studies
Probiotics and Infections in Children Attending Day Care Centres

NCT01014676

Sponsor

Valio Ltd

Status

Completed

Last Update Posted

Jul 7, 2011Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Respiratory Tract Infections
Gastrointestinal Diseases

Interventions

Probiotic
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 16, 2009

First Posted Date

Nov 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2011

Last Update Posted Date

Jul 7, 2011Estimated

Name	Class
University of Helsinki	OTHER

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Probiotic milk	Active Comparator		Dietary Supplement: Probiotic
Standard milk	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement		Probiotic milk
Placebo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 2 to 6 years in the beginning of the intervention
Attendance at a day care centre participating in the study (5 days a week)

Exclusion Criteria:

Milk allergy or lactose intolerance
Congenital heart diseases that requires regular medication
Malign diseases
Cytostatic treatment
Use of biological rheumatic medication
Continuous microbial medication
Regular use of oral corticosteroids (inhalable accepted)
Diabetes
Simultaneous participation in other clinical trials

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Pitkäranta, Professor	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Life Sciences Inc.		Kajaani and Oulu	Province of Oulu		Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27111772	Derived	Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016.

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D004066	Digestive System Diseases

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

ID	Term
D012141	Respiratory Tract Infections
D005767	Gastrointestinal Diseases